Analyst II, Product

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
The Product Analyst II analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. He/she/they is responsible for complaint handling per the Code of Federal Register (CFR) and all other international governmental regulations.  He/she/they will communicate event investigation results via regulatory reports and written communications, as appropriate.
 
 

Your responsibilities include:

⦁    Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
⦁    Apply clinical knowledge, as related to product application, to evaluate identified complaints.
⦁    Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analysis.
⦁    Participate in development and modification  of Regulator decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations (domestic and international).
⦁    Communicate with internal/external customers to gain insight into each complaint event.
⦁    Ensure complaint records, regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), global regulatory standards and internal procedures.
⦁    Author Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities.
⦁    Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
⦁    Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers. 
 

 
Required Qualifications:
• Minimum of a Bachelor’s Degree 
• Minimum of 2 years of complaint handling or related experience

 
Preferred Qualifications:
• Experience with Track Wise Global Complaint Management System
• Direct experience in writing and filing MDR and MDV reports
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook); experience with presentation applications such as PowerPoint and/or database applications such PowerBi.
• Solutions focused, continuous improvement mindset
• Critical thinking and ability to work independently with minimal supervision
• Excellent written and verbal communication skills 
• Must be self-motivated, goal-driven and results-oriented team player

Requisition ID: 563995

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!